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Commission Implementing Regulation (EU) 2018/1853 of 27 November 2018 granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of CVAS (Text with EEA relevance)

EU Regulation 2018/1853 · Adopted 27 November 2018 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Implementing Regulation (EU) 2018/1853

of 27 November 2018

granting a Union authorisation for the biocidal product family Teat disinfectants biocidal product family of CVAS

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsf1, and in particular Article 44(5) thereof,

Whereas:

(1)

On 28 August 2015, the Scientific Consulting Company — SCC GmbH acting on behalf of CVAS Development GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Teat disinfectants biocidal product family of CVAS (‘product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of Netherlands agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-WU019429-99 in the Register for Biocidal Products (‘the Register’).

(2)

The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and following the entry into application of the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100f2, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

(3)

On 30 August 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 19 March 2018, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of the product family and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 25 April 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 167, 27.6.2012, p. 1.

f2

Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

f3

ECHA opinion of 7 March 2018 on the Union authorisation of Teat disinfectants biocidal product family of CVAS (ECHA/BPC/193/2018).

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex Summary of product characteristics for a biocidal product family
  5. Part I: FIRST INFORMATION LEVEL
  6. ADMINISTRATIVE INFORMATION
  7. 1.1Family name
  8. 1.2Product type(s)
  9. 1.3Authorisation holder
  10. 1.4Manufacturer(s) of the biocidal products
  11. 1.5Manufacturer(s) of the active substance(s)
  12. PRODUCT FAMILY COMPOSITION AND FORMULATION
  13. 2.1Qualitative and quantitative information on the composition of the family
  14. 2.2Type(s) of formulation
  15. Part II: SECOND INFORMATION LEVEL — META SPC(S)
  16. META SPC 1
  17. META SPC 1 ADMINISTRATIVE INFORMATION
  18. 1.1Meta SPC 1 identifier
  19. 1.2Suffix to the authorisation number
  20. 1.3Product type(s)
  21. META SPC 1 COMPOSITION
  22. 2.1Qualitative and quantitative information on the composition of the meta SPC 1
  23. 2.2Type(s) of formulation of the meta SPC 1
  24. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
  25. AUTHORISED USE(S) OF THE META SPC 1
  26. 4.1Use description
  27. 4.1.1Use-specific instructions for use
  28. 4.1.2Use-specific risk mitigation measures
  29. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  30. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  31. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  32. 4.2Use description
  33. 4.2.1Use-specific instructions for use
  34. 4.2.2Use-specific risk mitigation measures
  35. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  36. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  37. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  38. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  39. 5.1Instructions for use
  40. 5.2Risk mitigation measures
  41. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  42. 5.4Instructions for safe disposal of the product and its packaging
  43. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  44. 6OTHER INFORMATION
  45. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  46. 7.1Trade name(s), authorisation number and specific composition of each individual product
  47. META SPC 2
  48. META SPC 2 ADMINISTRATIVE INFORMATION
  49. 1.1Meta SPC 2 identifier
  50. 1.2Suffix to the authorisation number
  51. 1.3Product type(s)
  52. META SPC 2 COMPOSITION
  53. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  54. 2.2Type(s) of formulation of the meta SPC 2
  55. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  56. AUTHORISED USE(S) OF THE META SPC 2
  57. 4.1Use description
  58. 4.1.1Use-specific instructions for use
  59. 4.1.2Use-specific risk mitigation measures
  60. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  61. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  62. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  63. 4.2Use description
  64. 4.2.1Use-specific instructions for use
  65. 4.2.2Use-specific risk mitigation measures
  66. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  67. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  68. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  69. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  70. 5.1Instructions for use
  71. 5.2Risk mitigation measures
  72. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  73. 5.4Instructions for safe disposal of the product and its packaging
  74. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  75. 6OTHER INFORMATION
  76. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  77. 7.1Trade name(s), authorisation number and specific composition of each individual product
  78. META SPC 3
  79. META SPC 3 ADMINISTRATIVE INFORMATION
  80. 1.1Meta SPC 3 identifier
  81. 1.2Suffix to the authorisation number
  82. 1.3Product type(s)
  83. META SPC 3 COMPOSITION
  84. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  85. 2.2Type(s) of formulation of the meta SPC 3
  86. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  87. AUTHORISED USE(S) OF THE META SPC 3
  88. 4.1Use description
  89. 4.1.1Use-specific instructions for use
  90. 4.1.2Use-specific risk mitigation measures
  91. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  92. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  93. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  94. 4.2Use description
  95. 4.2.1Use-specific instructions for use
  96. 4.2.2Use-specific risk mitigation measures
  97. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  98. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  99. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  100. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  101. 5.1Instructions for use
  102. 5.2Risk mitigation measures
  103. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  104. 5.4Instructions for safe disposal of the product and its packaging
  105. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  106. 6OTHER INFORMATION
  107. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  108. 7.1Trade name(s), authorisation number and specific composition of each individual product
  109. 7.2Trade name(s), authorisation number and specific composition of each individual product
  110. META SPC 4
  111. META SPC 4 ADMINISTRATIVE INFORMATION
  112. 1.1Meta SPC 4 identifier
  113. 1.2Suffix to the authorisation number
  114. 1.3Product type(s)
  115. META SPC 4 COMPOSITION
  116. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  117. 2.2Type(s) of formulation of the meta SPC 4
  118. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  119. AUTHORISED USE(S) OF THE META SPC 4
  120. 4.1Use description
  121. 4.1.1Use-specific instructions for use
  122. 4.1.2Use-specific risk mitigation measures
  123. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  124. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  125. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  126. 4.2Use description
  127. 4.2.1Use-specific instructions for use
  128. 4.2.2Use-specific risk mitigation measures
  129. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  130. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  131. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  132. 4.3Use description
  133. 4.3.1Use-specific instructions for use
  134. 4.3.2Use-specific risk mitigation measures
  135. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  136. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  137. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  138. 4.4Use description
  139. 4.4.1Use-specific instructions for use
  140. 4.4.2Use-specific risk mitigation measures
  141. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  142. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  143. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  144. 4.5Use description
  145. 4.5.1Use-specific instructions for use
  146. 4.5.2Use-specific risk mitigation measures
  147. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  148. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  149. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  150. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  151. 5.1Instructions for use
  152. 5.2Risk mitigation measures
  153. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  154. 5.4Instructions for safe disposal of the product and its packaging
  155. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  156. 6OTHER INFORMATION
  157. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  158. 7.1Trade name(s), authorisation number and specific composition of each individual product
  159. META SPC 5
  160. META SPC 5 ADMINISTRATIVE INFORMATION
  161. 1.1Meta SPC 5 identifier
  162. 1.2Suffix to the authorisation number
  163. 1.3Product type(s)
  164. META SPC 5 COMPOSITION
  165. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  166. 2.2Type(s) of formulation of the meta SPC 5
  167. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  168. AUTHORISED USE(S) OF THE META SPC 5
  169. 4.1Use description
  170. 4.1.1Use-specific instructions for use
  171. 4.1.2Use-specific risk mitigation measures
  172. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  173. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  174. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  175. 4.2Use description
  176. 4.2.1Use-specific instructions for use
  177. 4.2.2Use-specific risk mitigation measures
  178. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  179. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  180. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  181. 4.3Use description
  182. 4.3.1Use-specific instructions for use
  183. 4.3.2Use-specific risk mitigation measures
  184. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  185. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  186. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  187. 4.4Use description
  188. 4.4.1Use-specific instructions for use
  189. 4.4.2Use-specific risk mitigation measures
  190. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  191. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  192. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  193. 4.5Use description
  194. 4.5.1Use-specific instructions for use
  195. 4.5.2Use-specific risk mitigation measures
  196. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  197. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  198. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  199. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  200. 5.1Instructions for use
  201. 5.2Risk mitigation measures
  202. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  203. 5.4Instructions for safe disposal of the product and its packaging
  204. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  205. 6OTHER INFORMATION
  206. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  207. 7.1Trade name(s), authorisation number and specific composition of each individual product
  208. META SPC 6
  209. META SPC 6 ADMINISTRATIVE INFORMATION
  210. 1.1Meta SPC 6 identifier
  211. 1.2Suffix to the authorisation number
  212. 1.3Product type(s)
  213. META SPC 6 COMPOSITION
  214. 2.1Qualitative and quantitative information on the composition of the meta SPC 6
  215. 2.2Type(s) of formulation of the meta SPC 6
  216. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
  217. AUTHORISED USE(S) OF THE META SPC 6
  218. 4.1Use description
  219. 4.1.1Use-specific instructions for use
  220. 4.1.2Use-specific risk mitigation measures
  221. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  222. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  223. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  224. 4.2Use description
  225. 4.2.1Use-specific instructions for use
  226. 4.2.2Use-specific risk mitigation measures
  227. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  228. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  229. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  230. 4.3Use description
  231. 4.3.1Use-specific instructions for use
  232. 4.3.2Use-specific risk mitigation measures
  233. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  234. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  235. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  236. 4.4Use description
  237. 4.4.1Use-specific instructions for use
  238. 4.4.2Use-specific risk mitigation measures
  239. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  240. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  241. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  242. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
  243. 5.1Instructions for use
  244. 5.2Risk mitigation measures
  245. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  246. 5.4Instructions for safe disposal of the product and its packaging
  247. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  248. 6OTHER INFORMATION
  249. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
  250. 7.1Trade name(s), authorisation number and specific composition of each individual product
  251. META SPC 7
  252. META SPC 7 ADMINISTRATIVE INFORMATION
  253. 1.1Meta SPC 7 identifier
  254. 1.2Suffix to the authorisation number
  255. 1.3Product type(s)
  256. META SPC 7 COMPOSITION
  257. 2.1Qualitative and quantitative information on the composition of the meta SPC 7
  258. 2.2Type(s) of formulation of the meta SPC 7
  259. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
  260. AUTHORISED USE(S) OF THE META SPC 7
  261. 4.1Use description
  262. 4.1.1Use-specific instructions for use
  263. 4.1.2Use-specific risk mitigation measures
  264. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  265. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  266. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  267. 4.2Use description
  268. 4.2.1Use-specific instructions for use
  269. 4.2.2Use-specific risk mitigation measures
  270. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  271. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  272. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  273. 4.3Use description
  274. 4.3.1Use-specific instructions for use
  275. 4.3.2Use-specific risk mitigation measures
  276. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  277. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  278. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  279. 4.4Use description
  280. 4.4.1Use-specific instructions for use
  281. 4.4.2Use-specific risk mitigation measures
  282. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  283. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  284. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  285. 4.5Use description
  286. 4.5.1Use-specific instructions for use
  287. 4.5.2Use-specific risk mitigation measures
  288. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  289. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  290. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  291. 4.6Use description
  292. 4.6.1Use-specific instructions for use
  293. 4.6.2Use-specific risk mitigation measures
  294. 4.6.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  295. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  296. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  297. 4.7Use description
  298. 4.7.1Use-specific instructions for use
  299. 4.7.2Use-specific risk mitigation measures
  300. 4.7.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  301. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  302. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  303. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
  304. 5.1Instructions for use
  305. 5.2Risk mitigation measures
  306. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  307. 5.4Instructions for safe disposal of the product and its packaging
  308. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  309. 6OTHER INFORMATION
  310. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
  311. 7.1Trade name(s), authorisation number and specific composition of each individual product
  312. META SPC 8
  313. META SPC 8 ADMINISTRATIVE INFORMATION
  314. 1.1Meta SPC 8 identifier
  315. 1.2Suffix to the authorisation number
  316. 1.3Product type(s)
  317. META SPC 8 COMPOSITION
  318. 2.1Qualitative and quantitative information on the composition of the meta SPC 8
  319. 2.2Type(s) of formulation of the meta SPC 8
  320. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
  321. AUTHORISED USE(S) OF THE META SPC 8
  322. 4.1Use description
  323. 4.1.1Use-specific instructions for use
  324. 4.1.2Use-specific risk mitigation measures
  325. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  326. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  327. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  328. 4.2Use description
  329. 4.2.1Use-specific instructions for use
  330. 4.2.2Use-specific risk mitigation measures
  331. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  332. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  333. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  334. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
  335. 5.1Instructions for use
  336. 5.2Risk mitigation measures
  337. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  338. 5.4Instructions for safe disposal of the product and its packaging
  339. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  340. 6OTHER INFORMATION
  341. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
  342. 7.1Trade name(s), authorisation number and specific composition of each individual product
  343. 7.2Trade name(s), authorisation number and specific composition of each individual product
  344. META SPC 9
  345. META SPC 9 ADMINISTRATIVE INFORMATION
  346. 1.1Meta SPC 9 identifier
  347. 1.2Suffix to the authorisation number
  348. 1.3Product type(s)
  349. META SPC 9 COMPOSITION
  350. 2.1Qualitative and quantitative information on the composition of the meta SPC 9
  351. 2.2Type(s) of formulation of the meta SPC 9
  352. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
  353. AUTHORISED USE(S) OF THE META SPC 9
  354. 4.1Use description
  355. 4.1.1Use-specific instructions for use
  356. 4.1.2Use-specific risk mitigation measures
  357. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  358. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  359. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  360. 4.2Use description
  361. 4.2.1Use-specific instructions for use
  362. 4.2.2Use-specific risk mitigation measures
  363. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  364. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  365. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  366. 4.3Use description
  367. 4.3.1Use-specific instructions for use
  368. 4.3.2Use-specific risk mitigation measures
  369. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  370. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  371. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  372. 4.4Use description
  373. 4.4.1Use-specific instructions for use
  374. 4.4.2Use-specific risk mitigation measures
  375. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  376. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  377. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  378. 4.5Use description
  379. 4.5.1Use-specific instructions for use
  380. 4.5.2Use-specific risk mitigation measures
  381. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  382. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  383. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  384. 4.6Use description
  385. 4.6.1Use-specific instructions for use
  386. 4.6.2Use-specific risk mitigation measures
  387. 4.6.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  388. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  389. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  390. 4.7Use description
  391. 4.7.1Use-specific instructions for use
  392. 4.7.2Use-specific risk mitigation measures
  393. 4.7.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  394. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  395. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  396. GENERAL DIRECTIONS FOR USE OF THE META SPC 9
  397. 5.1Instructions for use
  398. 5.2Risk mitigation measures
  399. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  400. 5.4Instructions for safe disposal of the product and its packaging
  401. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  402. 6OTHER INFORMATION
  403. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
  404. 7.1Trade name(s), authorisation number and specific composition of each individual product